Division of Cardiology, Department of Internal Medicine, St. Carollo Hospital, Suncheon, South Korea.
Division of Cardiology, Department of Internal Medicine, Kyung Hee University Medical Center, Kyung Hee University, Seoul, Korea.
Coron Artery Dis. 2022 Dec 1;33(8):643-647. doi: 10.1097/MCA.0000000000001188. Epub 2022 Oct 14.
Drug-eluting stents (DES) significantly improved angiographic and clinical outcomes compared with bare-metal stents in patients with diabetes. The clinical effects of BioMime sirolimus-eluting stent (SES) in patients with diabetes have not been evaluated. Therefore, we compared the efficacy of BioMime DES in coronary artery disease (CAD) patients with versus without diabetes.
This prospective analytical study compared angiographic in-segment late loss and clinical effectiveness of BioMime SES stents in treating patients with (patients: 77 and lesions: 83) versus without (patients: 154 and lesions: 162) diabetes. The purpose of this study was the comparison of angiographic in-segment late loss at 12 months. Major adverse cardiac events (MACEs) were also monitored as secondary outcomes 24 months after the index procedure.
Of 231 patients enrolled in the study, the mean age was 63.3 years and 153 patients were male. Angiographic follow-up rate was 84.8% (patients: 196) and intravascular ultrasound (IVUS) follow-up rate was 67.9% (patients: 157) at 12 months. Diabetic patients were comparable to nondiabetic patients for 12-month in-segment late loss (0.01 ± 0.31 mm for the nondiabetes group versus 0.04 ± 0.11 mm for the diabetes group; P = 0.158; P < 0.05). At 24 months, MACEs, including death, myocardial infarction and ischemic-driven target lesion revascularization were not statistically different between the two treatment groups.
BioMime SES stents in treating patients with diabetes were comparable in reducing angiographic restenosis at 12 months and MACEs at 24 months compared to nondiabetic patients with CAD.
与金属裸支架相比，药物洗脱支架（DES）可显著改善糖尿病患者的血管造影和临床结局。尚未评估 BioMime 西罗莫司洗脱支架（SES）在糖尿病患者中的临床效果。因此，我们比较了 BioMime DES 在伴或不伴糖尿病的冠心病（CAD）患者中的疗效。
本前瞻性分析性研究比较了 BioMime SES 支架治疗伴（患者：77 例，病变：83 例）和不伴（患者：154 例，病变：162 例）糖尿病的 CAD 患者的血管造影节段内晚期丢失和临床疗效。本研究的目的是比较 12 个月时的血管造影节段内晚期丢失。主要不良心脏事件（MACEs）也作为次要结局在指数操作后 24 个月进行监测。
在纳入研究的 231 例患者中，平均年龄为 63.3 岁，153 例患者为男性。血管造影随访率为 84.8%（患者：196 例），血管内超声（IVUS）随访率为 67.9%（患者：157 例），随访时间为 12 个月。12 个月时，糖尿病患者的节段内晚期丢失与非糖尿病患者相当（非糖尿病组为 0.01±0.31mm，糖尿病组为 0.04±0.11mm；P=0.158；P<0.05）。24 个月时，两组间的 MACEs，包括死亡、心肌梗死和缺血驱动的靶病变血运重建，无统计学差异。
与非糖尿病 CAD 患者相比，BioMime SES 支架治疗糖尿病患者在 12 个月时降低血管造影再狭窄和 24 个月时降低 MACEs 的效果相当。
